None listed
Conditions
Interventions
Intervention1: Diphtheria and Tetanus vaccine (Adsorbed) for Adults and Adolescents (Td vaccine) of HBI: 0.5 ml single dose intramuscularly at the deltoid region.
Control Intervention1: BE Td�® Vacc
Sponsors
Human Biologicals Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy subjects of 10 years to 60 years of age. 2. Judged to be in good health on the basis of reported medical history, physical examination and clinical judgement of the investigator. 3. Plans to remain in the study area for the entire length of the trial. 4. Subject/Parent/LAR is literate and has understood and provided written Informed Consent and Assent form by Subjects of 10 years to below 18 years. 5. Past history of primary immunization with diphtheria and tetanus. 6. Negative urine pregnancy test for female subjects who have attained menarche, prior to the vaccination.
Exclusion criteria
Exclusion criteria: 1. Participation in any other clinical trial in the four weeks preceding the trial vaccination. 2. Planned participation in any other clinical trial during the present trial period. 3. Subject who has a known history of allergy to any component of the vaccine. 4. Known or suspected primary or acquired disease of the immune system. 5. Receiving allergy immunotherapy or immunosuppressive therapy. 6. History of any significant underlying disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, hematologic or hepatic dysfunction and autoimmune disease. 7. Known tetanus or diphtheria disease/infection within 5 years before inclusion 8. Known or suspected acute respiratory illness at the time of study vaccination with active symptoms and signs including one or more of the following: rhinorrhea, new cough, pharyngitis or any other respiratory problems (e.g. asthma, wheezing, shortness of breath). 9. Any fever with temperature â�¥ 38.0�°C (100.4oF) in last 3 days prior to the study vaccination. 10. Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures or evidence of any other evolving neurological signs and symptoms. 11. Any known history or suspicion of thrombocytopenia or a bleeding disorder. 12. Known history or suspicion of HIV, HCV or Hepatitis B. 13. Any history of receipt of blood products or immunoglobulins in last 3 months. 14. Subjects who have received any live attenuated vaccine in past 30 days and any subunit or inactivated vaccine in past 14 days. 15. Vaccinated with any diphtheria or tetanus containing vaccine within 5 years before inclusion. 16. History of recent contact with any confirmed case of COVID-19 or having tested positive for COVID-19 for less than a month. 17. Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ Proportion of subjects achieving seroconversion and seroprotection in each group on day 28 (+14 days) after a single dose of vaccination with Diphtheria and Tetanus vaccine (Adsorbed) for Adults and Adolescents (Td vaccine) of HBI.Timepoint: 28 days after a single dose of vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Seroprotection rate seroconversion rate and Geometric mean titres Number of adverse events during study periodTimepoint: 28 days after a single dose of vaccination | — |
Countries
India
Contacts
Public ContactDr S Sai Krishna
Human Biologicals Institute
Outcome results
None listed